In the current scenario of COVID-19, Infusion pump is considered as one of the critical products for immediate supply. But with the decline in the global supply chains of infusion pump, meeting the demand right on time would be challenging.
To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent infusion Pump manufacturer, you might be willing to market your product across the globe or to be specific in the USA. But do you know how infusion pump is classified in the USA? How United States Food and Drug Administration (US FDA) regulates infusion pump?
Have all your questions answered regarding:
- Infusion Pump Registration/notification in the USA
- US FDA Infusion Pump Regulations
In addition, some global health authorities have already expedited their Regulatory pathways for infusion pump. The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline infusion pump global market entry with the best of regional Regulatory information and structural Regulatory approach.
As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registrations/notifications of infusion pump in the USA.